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510(k) K915756

Device
BIOTRACK CARBAMAZEPINE TEST CARTRIDGE
Applicant
BIOTRACK, INC.
510(k) number
K915756
Product code
KLT  
Decision
Substantially Equivalent (SESE)
Decision date
1992-07-23
Date received
1991-12-23
Regulation
862.3645
Classification name
Enzyme Immunoassay, Carbamazepine
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JILL FINDLAY
Address
1058 Huff Ave. Mountain View CA US 94043 94043

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Legacy Summary#

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FDA Review#

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